Charlotte, NC – September 10, 2008 – BurnsAdler Pharmaceuticals, Inc. today announced today that it has entered into a collaboration with DOR BioPharma, Inc. (OTCBB: DORB) under which BurnsAdler will act as DOR’s distributor of a Named Patient Access Program (NPAP)for orBec® to patients suffering from acute gastrointestinal Graft-versus-Host disease (GI GVHD) in all countries within Central America, South America and the Caribbean (“Latin America”).
The NPAP is a compassionate use drug supply program under which medical practitioners can legally supply investigational drugs to their eligible patients. Under this program, investigational drugs can be administered to patients who are suffering from serious illnesses until the drug is approved by the various regional regulatory authorities. BurnsAdler and DOR will share revenues generated by sales of orBec® through the NPAP. DOR will manufacture and supply orBec® to BurnsAdler, while BurnsAdler will be responsible for all distribution costs in the Territory.
“We are very pleased to be working with DOR BioPharma on the NPAP for orBec®,” said Bryan Somerville , President of BurnsAdler. “There is an acute need for a new drug to treat GI GVHD as a result of hematopoietic stem cell transplantation in Latin America. Given the impressive pharmacology orBec® has shown as well as the fact that it is the first directed therapy for patients suffering from GI GVHD, we are glad to be able to make this innovative drug available to patients in Latin America.”
“We are pleased to be able to work with BurnsAdler to administer this important program,” stated Christopher J. Schaber, PhD, President and CEO of DOR. “We have great confidence in BurnsAdler and their ability to manage the NPAP in Latin America.”
Dr Schaber continued, “We have now established named patient access programs in over 60 countries. While we work to complete orBec®’s clinical development, we are continuing our worldwide strategy of generating revenues to support ongoing development programs while making this important therapy available now to patients suffering from acute GI GVHD wherever possible.”
DOR’s Named Patient Programs Partners for orBec®
|
DOR Named Patient Access Partner |
Territory |
|
BurnsAdler |
Mexico, Central and South America and the Caribbean |
|
IDIS |
European Union |
|
BL&H |
South Korea |
|
Pacific Healthcare |
Brunei, Cambodia, Indonesia, Laos, Myanmar, Philippines, Thailand and Vietnam |
|
Steward Cross |
Singapore and Malaysia |
|
Orphan Australia |
Australia, New Zealand and South Africa |
About DOR BioPharma, Inc.
DOR BioPharma, Inc. (DOR) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR’s lead product, orBec® (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of bone marrow transplantation. DOR filed a New Drug Application for orBec® with the FDA for the treatment of acute GI GVHD and received a not approvable letter in which the FDA has requested data from a confirmatory Phase 3 clinical trial to demonstrate the safety and efficacy of orBec®.
Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. DOR’s biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin, botulinum toxin and anthrax. DOR’s ricin toxin vaccine, RiVaxTM, has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.
About BurnsAdler Pharmaceuticals, Inc.
BurnsAdler Pharmaceuticals, Inc., a portfolio company of Bourne Capital Partners,LLC, is a specialty pharmaceutical company that promotes, sells and distributes products throughout Latin America, including Mexico, Puerto Rico and the Caribbean. Through relationships with product developers from the Unites States and Europe, BurnsAdler helps deliver world-class medicine to these challenging international markets. BurnsAdler’s portfolio strategy focuses on pharmaceutical products and medical devices used in oncology, gastroenterology, cardiovascular medicine, orthopedic medicine, hospitals and other critical care settings.
For additional information about this news release contact Bryan Somerville at +1.704.552.8410 Ext. 223. For additional information about BurnsAdler, please refer to the company’s website at www.burnsadler.com
